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NCT05196919 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy of XT-150 for Facet Joint Osteoarthritis Pain
A Phase 2 study, sponsored by Xalud Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 75
- Enrollment target
NCT05196919 is a Phase 2 study that has completed, run by Xalud Therapeutics. The registered enrollment target is 75 participants.
The verdict
NCT05196919, a Phase 2 study, has completed, sponsored by Xalud Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 75 participants
- Enrollment target
Study Summary
This is a Phase 2a safety and efficacy study of XT-150 in adult participants experiencing back pain due to inflammation of the facet joint, also known as facet joint osteoarthritis (FJOA), and who are eligible for intra articular glucocorticoid injection, or radiofrequency ablation of medial branches of the primary dorsal ramus of the exiting nerve root, which innervates the adjacent facet joints. Study drug will be administered at Day 0 and Day 90 by bilateral intra-articular (IA) injection into the facet capsule, at the affected spinal level (e.g. Lumbar \[L\]3-4, L4-5, or L5-Sacrum \[S\]1) as determined by imaging (e.g., Magnetic resonance imaging \[MRI\], Computed tomography \[CT\]), X-ray, etc.) and physical exam. Up to 72 participants will be randomized to placebo or one of two dose treatment groups (24 participants per treatment group). 1. 0.15 mg XT-150 (1.0 milliliter \[mL\] total delivered by two 0.5 mL injections) 2. 0.45 mg XT-150 (1.0 mL total delivered by two 0.5 mL injections) 3. Placebo (Sterile saline) (1.0 mL total delivered by two 0.5 mL injections)
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL XT-150
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2022-02-24 |
| Est. Completion | 2023-09-20 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05196919
The ClinicalTrials.gov registry entry for NCT05196919 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 75 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Xalud Therapeutics, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05196919 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05196919 about?
NCT05196919 is a clinical study titled "Safety and Efficacy of XT-150 for Facet Joint Osteoarthritis Pain". This is a Phase 2a safety and efficacy study of XT-150 in adult participants experiencing back pain due to inflammation of the facet joint, also known as facet joint osteoarthritis (FJOA), and who are eligible for intra articular glucocorticoid injection, or radiofrequency ablation of medial branche...
What is the current status of trial NCT05196919?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 75 participants. The study started on 2022-02-24. Estimated completion is 2023-09-20.
What interventions are being tested in trial NCT05196919?
The interventions under investigation include: Placebo (BIOLOGICAL), XT-150 (BIOLOGICAL).
Who is sponsoring clinical trial NCT05196919?
This trial is sponsored by Xalud Therapeutics, which has 4 total clinical trials registered on ClinicalTrials.gov.
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